Thursday, May 14, 2009

Positive Results for Medtronic's MRI-Safe Pacemaker

Filed under: Cardiac Surgery , Cardiology , Radiology

A clinical study evaluating the performance of Medtronic's EnRhythm MRI SureScan pacemaker has shown that the device is not subject to interference from magnetic resonance imaging. As the only pacemaker approved for MRI in the EU, the news may give the FDA enough guidance to also approve it as the first of its kind in the US.

Results showed that Medtronic's investigational EnRhythm MRI SureScan pacing system still performs as intended during and after an MRI when used according to the product's labeling. The data showed no MRI-related complications, and no arrhythmias, or asystole (absence of electrical activity in the heart) during MRI scans.

This prospective, randomized, controlled trial involved 464 individuals successfully implanted at 41 centers in the U.S., Canada, Europe and the Middle East. After successful implant of pacemaker and leads, 258 patients were randomized to MRI and 206 to no MRI (control). All patients were evaluated before and after the scan, and one week and one month after MRI scan/control visit. There was no difference in performance between the MRI group and the control group.

Press release: Medtronic Demonstrates Positive Results on First Pacemaker Designed for Use with MRI

Flashback: Medtronic Starts Study of MRI Compatible Pacemaker

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HELLO, MY NAME IS TERESA,I JUST HAD THE MEDTRONIC ENRHYTHM PACEMAKER PUT IN AT LIJ HOSPITAL ON AUGUST 24,2009.MY QUESTION IS,EVERY MORNING I AWAKE WITH A TERRIBLE HEADACHE. IS THIS NORMAL IN THE BEGINING? ALSO, MY LEFT ARM FEELS WEAK,AND WHEN I DO SLEEP (I SUFFER FROM LACK OF) I FIND 6 OUT OF 7 DAYS MY ARMS OR LEGS FEEL NEEDLES AND PINS,AS IF HEY HAVE FALLEN ASLEEP.
YESTURDAY,I WENT TO THE EMERGENCY ROOM IN KISSIMEE FLORIDA,(I RESIDE IN NYC,I AM ON VACATION)THE DAY BEFORE THE 22ND,I AWOKE FEELING AS IF SOMEONE WAS SITTING ON MY CHEST,THIS LASTED ABOUT 10 MINUTES,THEN ON THE 23RD,I AWOKE FEELING AS THOUGH MY AREA WHERE THE PACEMAKER IS WAS SENDING ELECTICITY ON MY CHEST,(HAVE YOU EVER PUT A SMALL TRANSISTOR BATTERY WITH 2 HEADS ON YOUR TONGUE,AND FELT THAT CURRENT?-LIKE THAT IN MY CHEST,FOR ABOUT 15 MINUTES. I CALLED MY DR IN NYC AND THE DR ON CALL SAID TO GO TO THE ER,THEYMADE ME WAIT FOR ABOUT 20 MINUTES TO CALL MY NAME,THEN ANOTHER55 MINUTES,JUST WAITING,I BECAME UPSET,BECAUSE THE MALE NURSE DURING THAT TIME SAID I MIGHT OF HAD A HEARTB ATTACK,INCREASING MY ANXIETY,FINALLY I WENT DOWN THE HALL ASKED ANOTHER NURSE WHY IT WAS TAKING SO LONG,,,,ALAS 10 MINUTES LATER A FEMALE DR SAID ALL WAS WELL WITH MY PACEMAKER ACCORDING TO THE EKG,SHE NEVER TOOK MY BLOOD,IV,OR ANYTHING ELSE.I WENT BACK TO MY HOTEL,NOW IT IS 1:15 AM,AND UNABLE TO FALL ASLEEP TILL 3:15AM. AT 5:15 I AM AWAKE WITH ANXIETY,AND A SPLITTING HEADACHE.
CAN YOU SHED ANY LIGHT ON ME? I AM TRULEY WORRIED.ALSO UPSET FOR THE LACK OF TREATMENT AT THE HOSPITAL.
THANK YOU
TERESA BONILLA
PS,I CAN BE REACHED AT 917-683-2332,PLEASE RESPOND BY PHONE ASASP,I AM REALLY NOT FEELING WELL.


Posted by: TERESA BONILLA
on September 25, 2009 03:30 AM GMT

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